Randomized study of anthracycline vs. TS-1 in patients with metastatic or recurrent breast cancer
- Conditions
- Metastatic or recurrent breast cancer
- Registration Number
- JPRN-UMIN000005449
- Lead Sponsor
- SELECT BC-CONFIRM executive committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 200
Not provided
1) HER2 (Her2/neu, Erb B2) IHC (3 +) or FISH (fluorescence in situ hybridization) (plus) for primary or metastatic lesion 2) Anaphylaxis against drugs or solvents used in protocol treatment 3) Active double cancers 4) Brain metastasis requiring treatment for increased intracranial pressure or requiring urgent irradiation 5) Extensive liver metastases or lymphatic lung metastases with dyspnea 6) Only one assessable lesion previously treated by radiotherapy 7) Retention of pleural fluid, ascitic fluid, or pericardial fluid requiring urgent treatment 8) Active infectious disease 9) Interstitial pneumonia or idiopathic interstitial pneumonia 10) HBs(+) 11) Diabetes mellitus that is poorly controlled or treated with insulin 12) Mental disease precluding participation in this study 13) Women who are pregnant, nursing infants,or plan to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Progression-Free Survival Time To Treatment Failure Adverse Events Health-Related QOL Cost-effectiveness